Tag: ISO 15223-1

ISO 15223-1 Medical Device Labeling Update!

For the first time since 2012, ISO 15223-1 has been updated.  The full title of this document is “Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General Requirements”.  This document will lay out for you all the requirements for a wide variety of medical device label symbols.  As I’m sure many of you current users of ISO 15223-1 already know, this standard is an important one.  If medical devices are your game, you’ll want to pick this one up ASAP.  It’s available now from Document Center as a paper copy or for PDF download.

Certain information must be conveyed when presenting a new medical device.  Much of this information is vitally important to the proper and safe use of the device.  It is also mandated by regulation in the US, EU, Canada, and many more. This can pose a problem when marketing a device that must be presented in various geographic locations and languages.  The solution to this problem?  Create a series of internationally recognized symbols, detailed within ISO 15223-1 2016 Edition.  This document was designed to take the confusion out of labeling medical devices in different languages.  In doing so, it helps to ensure the safe use of the products that it applies to.

Detailed within this text you’ll find a discussion of the scope of the document and who it applies to.  Requirements for usage of the medical device labels that are presented are covered.  Following this is an extensive “Symbols” section.  This includes a 16-page series of tables showing the symbols themselves.  It also provides their titles, descriptions, requirements, and informative notes.

The document finishes with two informative annexes.   Annex A gives practical examples of how each symbol is used to convey information.  Some examples are manufacturing location, use-by date, and batch code.  Annex B provides guidance on general prohibition and negation symbols.

Do you need a copy of ISO 15223-1 2016?  Contact us at Document Center.  Here’s a link to the order page for ISO 15223-1. If you need to provide a document for multiple users, make sure to ask about our site-wide subscriptions.  You can also visit our website (www.document-center.com) and browse our standards library.

If you have questions regarding ISO 15223-1 or other standards, just give us a call (650-591-7600) or send us an email (info@document-center.com).  We’ve been an authorized distributor of ISO standards for thirty years.  Make us your Standards Experts!

 

Document Center’s 20 Top Selling Standards of 2012

Yes, it’s time to review Document Center‘s top selling standards of 2012.  Do you use any of these popular items?

  1. BS EN ISO 13485, New 2012 Edition, Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes
  2. BS EN ISO 14971, New 2012 Edition, Medical Devices. Application of Risk Management To Medical Devices
  3. ISO 15223-1, New 2nd Edition, Medical Devices – Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied – Part 1: General Requirements
  4. BS EN ISO 15223-1 (paper or CD Rom format), New 2012 Edition (replaces BS EN 980), Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling and Information To Be Supplied. General Requirements
  5. ASTM F2096, 2011 Edition, Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
  6. AMS 2750, New Revision E, Pyrometry
  7. 21 CFR Parts 800-1299, 2012 Edition, Code of Federal Regulations – Title 21–Food and Drugs (Parts 800 To 1299)
  8. ISO 19011, 2011 Edition, Guidelines for Auditing Management Systems
  9. SOR/98-282, 2012 Consolidated Edition, Medical Devices Regulations (Canada)
  10. IEC 60601-1, Consolidated Edition 3.1 with Corrigendum, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
  11. MEDDEV 2.12/1, New 8th Revision, Guidelines on a Medical Devices Vigilance System
  12. ASTM E1417, 2011 Edition with Editorial Change, Standard Practice for Liquid Penetrant Testing
  13. ASTM E18, 2011 Edition, Standard Test Methods for Rockwell Hardness of Metallic Materials
  14. ASTM A370, 2012A Edition, Standard Test Methods and Definitions for Mechanical Testing of Steel Products
  15. IPC-A-610, Revision E, Acceptability of Electronic Assemblies
  16. ISO 11137-2, 2012 Edition, Sterilization of Health Care Products – Radiation – Part 2: Establishing the Sterilization Dose
  17. ASTM A240/A240M, 2012A Edition, Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
  18. ASQ Z1.4, 2008 Edition, Sampling Procedures and Tables for Inspection by Attributes
  19. ISTA 2A, 2012 Edition, Performance Tests for Packaged-Products, Packaged-Products 150 Lb (68 Kg) or Less
  20. IPC/WHMA-A-620, Revision B, Requirements and Acceptance for Cable and Wire Harness Assemblies  — tied with the all time favorite: ISO-9000, 2005 Edition, Quality Management Systems – Fundamentals and Vocabulary

All these standards are available from Document Center Inc. at our webstore, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here to assist you with both your standards purchases and the services you need to maintain your standards collection.

BS EN 980 replaced by new release BS EN ISO 15223-1, Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling And Information To Be Supplied. General Requirements

For all of you in the medical device field, the BS EN 980 (Official English language edition of EN-980) “Symbols for use in the labelling of medical devices” has been a must-have in your conformance documentation collection.  Now the European standard has been withdrawn and replaced by the new 2012 issue of BS EN ISO 15223-1, “Medical Devices. Symbols To Be Used With Medical Device Labels, Labelling And Information To Be Supplied. General Requirements.”  Available at Document Center Inc., the new integrated standard provides consolidated International and European requirements for symbols used in medical device labelling.

The text of ISO 15223-1:2012 was approved by CEN as a EN ISO 15223-1:2012 without any modification.  Use of the standard is a means of conforming to the New Approach Directive 93/42/EEC on medical devices.

In addition to the text of ISO 15223-1, the EN adoption BS EN ISO 15223-1:2012 contains three informative Annexes.  The first is Annex ZA, “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical device.”  The second is Annex ZB, “Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices.” And the third is Annex ZC, “Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices.”

Expect to see more adoptions of the ISO 15223-1:2012 across various jurisdictions during the next few months.

All these documents plus a wide variety of other standards used by the Medical Device Industry are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone at +650-591-7600, fax at +650-591-7617 or by email at info@document-center.com.  You may also want to review our other audit and monitoring services for standards that are particularly helpful to organizations who are required to pass conformance audits on a regular basis.

 

New ISO 15223-1 2012 Edition, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements, replaces EN 980

ISO 15223-1:2012, “Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements,” has just been released and is now available from Document Center Inc.   This second edition cancels and replaces the first edition (ISO 15223-1:2007) which has been technically revised. It also incorporates the amendment ISO 15223-1:2007/Amd.1:2008.

This part of ISO 15223 constitutes a technical revision of both ISO 15223-1:2007 and EN 980:2008, combining the symbols and requirements of both standards for the first time. There has been a steady convergence of the symbol requirements in ISO 15223-1 and EN 980 over recent years, with many of the previous differences between the standards resolved.  Users of EN 980, “Symbols for use in the labelling of medical devices,” will want to upgrade to EN ISO 15223-1, 2012 Edition, as the EN 980 is now withdrawn and obsolete.

ISO 15223-1 represents a significant advance in the safe and effective use of symbols to transcend language, giving manufacturers, regulators and others a single set of global symbols for use with medical devices.  The standard is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.  These symbols presented may be used on the medical device itself, on its packaging or in the associated documentation.

All current ISO standards and many of the obsolete revisions are available from Document Center Inc. at our website, www.document-center.com.  They are available in paper format or in the United States as pdf format as well.  You may want to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We are here to assist you with any standards-related questions or requirements.

ISO 15223 Series on Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

ISO 15223 has been around since 1998, but in 2007 it was split into 2 parts covering two distinct topics.  We often sell this set here at Document Center Inc. so I thought you might appreciate a brief synopsis of the two documents.

ISO 15223-1:2007 is titled “Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements.”  Note the English spelling for labeling.  All ISO standards are published using the English spelling, not the American.  The standard is not complete without Amendment 1, ISO 15223-1:2007/Amd 1:2008.  So be sure to order both items when you purchase the standard.

ISO 15223-1:2007 identifies requirements for the development and use of symbols that may be used to convey information on the safe and effective use of medical devices. It also lists symbols that satisfy it’s requirements.

ISO 15223-1:2007 is limited to symbols applicable to a broad spectrum of devices that may be marketed globally. These symbols may be used on the device itself or its package or in the associated documentation.

ISO 15223-2:2010, titled “Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation,” specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.

The purpose of ISO 15223-2 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.

If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.

ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

These standards, and all ISO and IEC documents, are available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re happy to answer any questions you may have about these publications.